Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305357
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2006-03-17
Brief Title:
Evolution of Pain From Herpes Zoster
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Evolution of Pain and Neural Dysfunction From Acute Herpes Zoster to Post-Herpetic Neuralgia
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evolution of pain and neural injury will be evaluated at 2 years or longer after the onset of AHZ by multiple measures Assessments at 2 years or longer will be compared to those collected during the first 6 months after HZ in order to test whether or not sensory function and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from HZ without severe PHN
Detailed Description:
Pain nerve trunk inflammation and neuronal injury are hallmarks of acute herpes zoster AHZ We hypothesize that the development of post-herpetic neuralgia PHN strongly depends on two factors 1 the severity of the initial neural injury and 2 the ability to recover from the initial neural injury To test this hypothesis we will prospectively follow 150 patients at high risk for development of PHN Evolution of pain and neural injury will be evaluated at 2-6 weeks 6 weeks 3 months 6 months and at 2 years or longer after the onset of AHZ by multiple measures Assessments at 2 years or longer will be compared to those collected during the first 6 months after HZ in order to test whether or not sensory function and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from HZ without severe PHN
Preliminary analysis of study data showed reduced innervation in HZ skin mirror image skin and distant control skin in the acute phase of HZ that was not specific to the persistence of pain at 3 months The innervation appeared to recover more fully by 6 months in distant control skin than in mirror-image skin and HZ skin despite the fact that the subjects were continuing to experience a further reduction in their zoster-associated pain This suggests that the symptoms of pain and sensory dysfunction are not due to a mere loss in overall innervation density The proposed subsequent 2 year study visit and analysis will allow us to directly correlate pain resolution with resolution of sensory and innervation abnormalities
Preliminary analysis of study data showed reduced innervation in HZ skin mirror image skin and distant control skin in the acute phase of HZ that was not specific to the persistence of pain at 3 months The innervation appeared to recover more fully by 6 months in distant control skin than in mirror-image skin and HZ skin despite the fact that the subjects were continuing to experience a further reduction in their zoster-associated pain This suggests that the symptoms of pain and sensory dysfunction are not due to a mere loss in overall innervation density The proposed subsequent 2 year study visit and analysis will allow us to directly correlate pain resolution with resolution of sensory and innervation abnormalities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None